Food Effect and Bioavailability of Deflazacort Formulations in Healthy Volunteers

This is a Phase 1, single-center, single-dose, randomized, 5-period crossover study designed to assess the comparative bioavailability and food effect of deflazacort. A total of 45 subjects will be randomly assigned to 1 of 5 treatment sequences. Each dosing sequence will be enrolled in parallel and will receive all 5 treatments in a crossover fashion. Subjects will be screened within 28 days of the first dose of study drug. Subjects will check into the clinical pharmacology unit (CPU) on the day prior to dosing (Day -1 for Period 1) and will stay in-house through the 24 hour assessments in each study period. Safety assessments will be performed at screening, check-in for each period, and at 24 hours after each dose per the Schedule of Assessments .Additionally, a safety follow-up phone call will be performed on Day 36 (± 2 days). Subject participation is expected to last approximately 64 days, including a 28-day screening period and a 36-day on study period (consisting of 5 treatment periods, washout periods lasting 7 days, and the safety follow-up phone call).